Kornimate/medical-research-clean huggingface dataset:
long-term safety of twice daily oxycodone hydrochloride controlled-release tablets in children who completed otr3001

Conditions: Pain

Summary: the purpose of this study is to characterize the long-term safety of oxycodone hydrochloride (hcl) controlled-release (cr) tablets in opioid experienced pediatric patients aged 6 to 17 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy who completed the 4 -week treatment period in otr3001.


Eligibility criteria:
inclusion criteria include: 1. male and female patients aged 6 to 17 years, inclusive, who completed the 4-week study drug treatment in study otr3001 and who, based on the investigator's judgment, will benefit from continuing treatment with oxycodone hcl cr 20 to 240 mg/day for the management of moderate to severe malignant or nonmalignant pain; 2. patients must have tolerated the oxycodone hcl cr therapy in otr3001 as demonstrated at the start of the study; 3. patients must be willing and able to swallow the oxycodone hcl cr tablets whole. exclusion criteria include: 1. patients with ongoing adverse events in otr3001 that, in the investigator's opinion, disqualify them from participation in the study; 2. female patients who are pregnant or lactating; 3. patients requiring opioid at doses equivalent to \ 240 mg/day oxycodone for treatment of their malignant or nonmalignant pain; 4. patients who are allergic to oxycodone or have a history of allergies to other opioids (this criterion does not include patients who have experienced common opioid side effects \[eg, nausea, constipation\]); 5. patients who are contraindicated for the use of opioids; 6. patients who are currently being maintained on methadone for pain; 7. patients who have an abnormality on vital signs, physical examination, or laboratory testing significant enough that the investigator deems the patient is not appropriate for the study; 8. patients who have any planned surgery during the course of the study, with the exception of the placement of central or peripheral venous access devices; 9. patients currently taking an investigational medication/therapy other than the study drug (oxycodone hcl cr) at the start of screening or during the study. other protocol specific inclusion/exclusion criteria may apply.

Keywords: malignant pain nonmalignant pain pain pediatric opioid moderate to severe
laparoscopic surgery for t4 tumor of the colon cancer

Conditions: Colonic Neoplasms

Summary: the purpose of this study is to compare the short- and long-term survival of laparoscopic surgery and conventional open surgery for t4 colon cancer.

the investigators previous study indicated that laparoscopic surgery is feasible in t4 colon cancers with comparable clinical and oncologic outcomes. laparoscopy can be considered as an alternative approach for t4 colon cancers with the advantage of faster recovery. however, the clinical value of laparoscopic surgery for t4 colon cancer was only validated in some retrospective study and some prospective study in single institute with small sample of patients. the aim of the present study is to compare the short-and long-term survival outcomes of laparoscopic surgery and conventional open surgery for t4 colon cancer as well as the mortality and the morbidity. the number of patients needed to get a 80% power is 1960. the average number of patients/surgical center is approximately 200 in each of 10 surgical centers. the preoperative, intraoperative and postoperative period will be in complete accordance with the usual care of the center. the baseline demographics and conditions as well as the perioperative items and the postoperative occurrences will be recorded through a prior designed e-questionnaire. systematically analyze and compare the disease free survival rate, the mortality, the morbidity, and the proportion of completion of laparoscopic surgery of the two surgical strategies (laparoscopy vs conventional open surgery).

Eligibility criteria:
inclusion criteria: * able to provide written informed consent * histologically confirmed diagnosis of colon carcinoma * ct or mri verified as t4 colon cancer without involvement of other organs * without multiple lesion other than carcinoma in situ * tumor size \< 8 cm * no bowel obstruction * sufficient organ function * no history of gastrointestinal surgery * 18 years of age or older * performance status (ecog) 0, 1 or 2 and life expectancy \> 12 weeks * operable patients exclusion criteria: * women who are pregnant (confirmed by serum b-hcg in women of reproductive age) or breast feeding * unstable or uncompensated respiratory or cardiac disease * serious active infections * hypersensitivity to capecitabine/fluorouracil or oxaliplatin * stomatitis, ulceration in the mouth or gastrointestinal tract * severe diarrhea * peripheral sensory neuropathy with functional impairment

Keywords: colonic neoplasms laparoscopic surgery t4
dose escalation study of pasireotide (som230) in patients with advanced neuroendocrine tumors (nets)

Conditions: Neuroendocrine Tumors

Summary: this study designed to determine the maximum tolerated dose (mtd) for patients with advanced neuroendocrine tumors (nets) and to characterize the safety, tolerability, pharmacokinetics and preliminary efficacy of pasireotide lar administered i.m. once every 28 days.


Eligibility criteria:
inclusion criteria: * ≥18 yrs old, histologically confirmed advanced well or moderately differentiated neuroendocrine tumor/carcinoma * unresectable metastatic net tumor with measurable disease * life expectancy ≥ 12 weeks exclusion criteria: * patients with cns metastases who are neurologically unstable or requiring increasing doses of steroids to control their cns disease * patients with known hypersensitivity to somatostatin analogs * patients with symptomatic cholelithiasis in the past 2 months * patients with history of another known primary malignancy with exception of non-melanoma skin cancer or carcinoma in situ of uterine cervix * patients with known history of hepatitis c or chronic active hepatitis b * patients with diagnosis of hiv. other protocol-defined inclusion/exclusion criteria may apply

Keywords: mtd pasireotide lar nets advanced neuroendocrine tumors
clinical investigation to evaluate the performance of hyaluronic acid for the treatment of hypertrophic scars

Conditions: Hypertrophic Scar

Summary: the study includes two study groups, one involves treatment with auto-cross-linked hyaluronic acid by intralesional and hypodermic injection, repeated after two weeks (t14), while the control arm provides an equal treatment but with isotonic saline solution. enrolled patients will be randomized into 2 groups with an allocation of 2:1 in study treatment arm and control arm respectively. they will be evaluated using the posas scale before the treatment and re-evaluated at 30, 90 and 180 days after treatment. the scar evaluation will be completed by an ultrasound assessment at time 0 (t0), 30 (t30), t90 and t180 and the dlqi (dermatology life quality index) to be assessed at time 0 (t0), 30 (t30), 90 (t90) and 180 (t180). in subjects that will consent, a small surgical biopsy for an explorative evaluation of the scar tissue will be performed before (t0) and after treatment (t30) for a histological assessment.


Eligibility criteria:
inclusion criteria: * signed written informed consent * male or female subjects aged ≥ 18 and ≤ 85 years * subjects with hypertrophic scars caused by trauma, burn or iatrogenic injury with or without involvement of the mobile joints * scar \> 2 to \< 25 cm2 of surface * scar not previously treated with corticosteroids, laser or other invasive treatments * scar present for at least 12 months * scar located in all areas of the body with the exception of the face and neck * fitzpatrick skin score of i-vi * subjects willing to comply with all the steps of treatment and follow-up visits * subjects willing to refrain from any cosmetic intervention in the area to be treated during the clinical investigation * female of child-bearing potential (i.e. not in menopausal status from at least one year or permanently sterilized) must have a negative urine pregnancy test prior the first treatment exclusion criteria: subjects with type i and type ii diabetes mellitus * subjects with oncological diseases in progress or in remission * subjects receiving immunosuppressive drugs and corticosteroids, anticoagulants, antiplatelet agents * subjects with autoimmune diseases including connectivitis * subjects with congenital or acquired immunodeficiencies (including metabolic ones) * subjects with known allergy or hypersensitivity to hyaluronic acid or its derivatives * participation in clinical trials/investigations in the last 30 days * pregnant or breastfeeding women * if female and of child-bearing potential, subject not using a highly effective method of birth control and not willing to use it during the participation to the clinical investigation * subjects not willing to avoid tanning during the clinical investigation * subjects with inflammations of the skin, including rosacea * subject with skin infection in the area to be treated * subjects having a high probability of non-compliance with the study procedures according to investigator's judgement
access natriuretic peptide assay(s) pivotal - emergency department subject enrollment and specimen collection

Conditions: Heart Failure

Summary: the purpose of the pivotal study is to collect blood specimens and clinical data from patients suspected of having heart failure (hf), which will be tested at a future date on natriuretic peptide assay(s) to validate diagnostic cutoffs and assess hf severity.

a prospective clinical sample collection and future natriuretic peptide testing will be conducted in an emergency department only population. patients presenting to the emergency department (ed) with signs and symptoms of acute heart failure will be approached for enrollment. clinical and laboratory data will be collected to establish product performance and clinical concordance to adjudicated clinical diagnosis. approximately 1800 evaluable subjects at geographically dispersed sites in the us will be enrolled in the study. sample collection and testing of clinical samples with the access natriuretic peptide assay will be performed under two separate protocols

Eligibility criteria:
inclusion criteria: * signed and dated informed consent obtained * adult aged 21 years or older * presenting with a clinical suspicion of acute hf * subject clinical history available for review by sponsor or delegates and fda or other regulatory agencies exclusion criteria: * dyspnea clearly not secondary to hf (e.g. primary lung disease or chest trauma) * stage 4 or 5 chronic kidney disease (ckd) * chronic dialysis * participation in a clinical study that may interfere with participation in this study * anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Keywords: natriuretic peptide
the effect of independent obstetric operating room on decision-to-delivery interval for emergency cesarean section

Conditions: Emergency Cesarean Section

Summary: the study is to investigate whether the establishing independent obstetric operating centre can shorten the decision-to-delivery interval and improve delivery outcomes of emergency cesarean section.

the newest define of decision-to-delivery interval (ddi) is the interval between the time at which the senior obstetrician makes the decision that a caesarean section is required and the time at which the fetus (or first fetus in the case of multiples) is delivered. the recommended ddi by the american college of obstetricians and gynecologists and the royal college of obstetricians and gynecologists is within 30 minutes. the 30 minutes rule is also used to measure the overall performance of an obstetric unit in our country. lower rate of ddi over 30 minutes will improve the outcome of neonatal outcomes. affiliated foshan maternity \& child healthcare hospital is a tertiary care hospital in south of our country. obstetric operations in this hospital are used to perform in a big general operating center, which is shared by all departments of the hospital. in december 23, 2020, a new wing of the hospital opened in response to the growing number of patients. in the new wing, an independent obstetric operating center was established to provide health care for obstetric operating. the original and new obstetric units were built according to the same standard. the medical staff shifts between original and new obstetric units every three months. six months after the new wing of hospital opened, we set off a randomized and controlled trial (rct). the rct is aimed to investigate whether the independent obstetric operating center can shorten the ddi, decrease the rate of ddi over 30 minutes and improve neonatal outcomes. women who are over 18 years old, meet the conditions of vaginal delivery and decided to give birth vaginally by doctor and patient will be random distributed to original or new obstetric unit from july 1, 2021 to june 30,2022. women need ecs in original obstetric unit will be send to the general operating center (named standard group), those need ecs in the new wing will be send to the obstetric operating center (named new group). ddi and other related variables of those who need ecs will be recorded. data of a total of 60 ecs in each group will be collected and analyzed at last. women who with missing data should be excluded.

Eligibility criteria:
inclusion criteria: * over 18 years old, meet the conditions of vaginal delivery, decided to give birth vaginally exclusion criteria: * with missing data

Keywords: independent obstetric operating room emergency cesarean section decision-to-delivery interval
effectiveness of the routine use of extubation protocol on the incidence of occurrence of failures number of extubation in pediatric resuscitation

Conditions: Respiratory Insufficiency

Summary: the failure of extubation in pediatric resuscitation is most often described as the need for reintubation within 48 hours after extubation. the failure rate of extubation in pediatric intensive care varies in the literature there is between 4 and 22% failures. these failures result in increased mortality, morbidity with a use of larger tracheostomy, a prolonged residence time. the extubation is codified in adult resuscitation and tends to be increasingly in pediatric resuscitation. in the pediatric intensive care unit of hautepierre, a extubation protocol already exists for some time, and was prepared to go. the current literature data. it allows the harmonization of practices in service (previously left to the discretion of each doctor). the investigators are looking to see if the protocol used systematically in the service enables a reduction in the incidence of occurrence of failures of extubation.


Eligibility criteria:
inclusion criteria: * children hospitalized in pediatric intensive care, under 18 years, intubated, ventilated for more than 2 hours and for which planning extubation or intubated children for whom an unplanned extubation just happened. * children whose holding parental authority are not opposed to the use of clinical data from their child for research purposes. exclusion criteria: * refusal to participate in the study

Keywords: extubation pediatric resuscitation reintubation failures of extubation.
cross-cultural adaptation of the greek version of disability assessment for dementia

Conditions: Dementia

Summary: the main purpose of this study is primarily the translation and cross-cultural adaptation into greek and then the investigation of validity and reliability in the greek target population.

two investigators will do the translation into greek, then a third person independent of the first two will translate the scale backward, i.e. into english. then, the three investigators will meet with another independent investigator who is familiar with the field of greek translations of foreign language rating scales. thus, the final translation and greek version of the scale will be created. then, the process of finding the participants will begin and the first assessment with the scale will be carried out initially. after two days will take place reassessment for the reliability of the measurement tool. in order to find the validity of the scale in the greek population, in the first assessment will be used also katz index for basic activities of daily living and the lawton scale for instrumental activities of daily living.

Eligibility criteria:
inclusion criteria: * be diagnosed with any type of dementia * have a carer * have a good cognitive level exclusion criteria: * be end-stage or bedridden
clinical outcomes of cyclosporine eye drops in management of herpetic keratitis

Conditions: Outcomes of Cyclosporine Eye Drops in Herpetic Keratitis

Summary: objective: to compare the additive effect of topical cyclosporine a 0.05% eye drops to prednisolone eye drops, with topical prednisolone acetate 1% eye drops alone in treatment of herpetic stromal keratitis. methods: patients diagnosed with herpetic stromal keratitis are randomly divided into 2 groups; group a: receive cyclosporine eye drops together with prednisolone eye drops. group b: receive topical prednisolone with placebo eye drops (tear replacement). the 2 groups receive systemic acyclovir therapeutic dose 400 mg five times daily, which then tapered to twice daily prophylactic dose after one month of treatment. follow up for patients is scheduled as a weekly visit for a duration of 2 months.


Eligibility criteria:
inclusion criteria: * patients diagnosed with herpetic stromal keratitis exclusion criteria: * associated ocular diseases, dm, renal disease, pregnancy, breast feeding.
dydrogesterone in the treatment of endometrial polyps

Conditions: Endometrial Polyp

Summary: this study is intended to observe the therapeutic effect of dydrogesterone on endometrial polyps and provide a reference for clinical treatment.

endometrial polyps are a common female endometrial lesion.the long-term unrestrained exposure of estrogen to local tissue is one of the causes of polyp formation.studies suggested that the progesterone can accelerate the regression rate of endometrial polyps due to its antiestrogenic effects.based on this, investigators intended to observe the therapeutic effect of dydrogesterone on endometrial polyps and provide a reference for clinical treatment.

Eligibility criteria:
inclusion criteria: 1. women of childbearing age from 20 to 50 years old 2. with or without menstrual changes: 1. menostaxis (longer than 7 days) 2. shortened menstrual cycles(less than 23 days) 3. menorrhagia(more than twice as much as usual) 4. abnormal vaginal bleeding(non-menstrual vaginal bleeding) 3. with following signs of vaginal ultrasound in the follicular phase (day 1 to day 10 of a menstrual cycle): 1. typical signs with a suspect of ep: (median/high) echo with a regular contour within the uterine lumen; 2. atypical signs with a suspect of ep: punctate cystic areas within the endometrium and the endometrial thickness \>1cm; exclusion criteria: 1. no menses within half a year; 2. surgery or drug treatment of endometrial lesions in the past half year; 3. with current intrauterine device; 4. combined with other acute gynecological inflammation; 5. with clinically suspected malignant tumors; 6. long-term use of oral contraceptives; 7. with abnormal liver and kidney function; 8. with benign or malignant breast tumors; 9. with any systemic malignant tumor or a history of tumors; 10. participants who are pregnant.
neurologic outcome after mitral valve surgery

Conditions: Mitral Valve Reconstruction

Summary: reconstructive mitral valve surgery is increasingly done by minimal- invasive anterolateral thoracotomy technique in contrast to surgical approach by sternotomy. the minimal invasive approach is favourable regarding surgical trauma, length of hospital stay and amount of blood loss. this study is to investigate the neurological outcome after minimal- invasive mitral valve surgery compared to open mitral valve surgery by sternotomy. pre-, intra- and postsurgical data from mitral valve surgery derived from the basel mitral valve registry (collected from 2009 until now) will be analyzed.


Eligibility criteria:
inclusion criteria: * surgery for mitral valve (reconstruction or replacement) (maybe combined with surgery for tricuspid valve and/ or surgery for atrial septal defects and/or patent foramen ovale) exclusion criteria: * other surgical interventions then the surgical interventions mentioned in the inclusion criteria * pre- existing neurological deficit; neurologic limitation in daily life * emergency surgery

Keywords: mitral valve surgery mitral valve stenosis mitral valve insufficiency minimal invasive mitral valve surgery neurological outcome
magnetocardiography as a noninvasive diagnostic strategy for identifying coronary allograft vasculopathy

Conditions: Coronary Allograft Vasculopathy (CAV)

Summary: purpose: to show early feasibility of magnetocardiography (mcg) to identify coronary cardiac positron emission tomography (pet) is the preferred non-invasive tests to assess for cav and incorporation of quantitative myocardial blood flow (mbf) assessment improves diagnostic accuracy. based on ishlt criteria, the following have been proposed for diagnosis of cav by pet:

diagnosing cav by pet with quantitative myocardial blood flow (mbf) 3 pet cav 0: normal perfusion with normal global stress (\> 1.7 ml/min/g) pet cav 1: normal perfusion with abnormal global stress mbf (\ 45%) or single vessel perfusion defect with normal global stress mbf. pet cav 2/3: normal perfusion with abnormal global stress mbf (\<1.7 ml/min/g) and ejection fraction \< 45% or single vessel perfusion defect with abnormal global stress mbf (\<1.7 ml/min/g) or multivessel perfusion defects with these diagnostic criteria, pet cav 0 has been shown to have a high negative predictive value for moderate to severe cav by invasive coronary angiography, and pet cav 2/3 has been shown to have a high positive predictive value for moderate to severe cav and is associated with adverse events. this study further examines the feasibility of mcg in identifying cav in adult heart transplant recipients and compares those results to the current non-invasive standard using pet cav scores. this will help determine whether mcg is a potential test for regular surveillance of cav in transplant recipients.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age at the time of enrollment willing to provide written informed consent completed cardiac pet within the last 2 weeks no changes to medication or intervention since the pet was completed exclusion criteria: * patients unable to fit into device patients unable to lie supine for 5 minutes patients with implanted ferromagnetic objects above the costal margin of the rib cage (implanted pacemakers, cardioverter/defibrillators, infusion pumps, and/or neuro stimulators). note: sternotomy wires stents are acceptable implanted pacemakers or cardioverter/defibrillators implanted infusion pumps and/or neuro stimulators severe claustrophobia

Keywords: magnetocardiography
a study using botulinum toxin type a in adolescents with axillary hyperhidrosis

Conditions: Hyperhidrosis

Summary: a study using botulinum toxin type a in adolescents with axillary hyperhidrosis.


Eligibility criteria:
inclusion criteria: * marked axillary hyperhidrosis exclusion criteria: * previous use of botulinum toxin for hyperhidrosis
endocannabinoids in end stage renal disease

Conditions: End Stage Renal Disease; Nutrition

Summary: to investigate the relationship between dietary intake, body habitus, and endocannabinoid levels in end stage renal disease patients as compared to matched controls.


Eligibility criteria:
inclusion criteria: * hemodialysis patient, able to give informed consent exclusion criteria: * hospitalization in past 3 months